Biogen, Inc.'s decade-long Aduhelm (aducanumab) story line took many twists and turns over the course of its development, capturing national attention in 2021 when the drug became the first anti-amyloid antibody to reach the US market for Alzheimer’s disease on scant efficacy evidence and quickly fading from the spotlight when the hyped commercial launch failed and a second anti-amyloid drug from Eisai Co., Ltd. and Biogen, Leqembi (lecanemab), gained full approval from the US Food and Drug Administration in 2023.
Biogen Closes The Book On The Aduhelm Saga
Biogen will end the development and commercialization of Aduhelm, the first anti-amyloid antibody drug to reach the US market for Alzheimer’s, including the confirmatory ENVISION trial. Product’s legacy includes an FDA that appears less enthusiastic about accelerated approvals for large indications and a CMS that is more interested in label-driven reimbursement decisions.
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